MAUDE Adverse Event Report: NOVAMED (ANTALYA) MULTIFILTRATEPRO HDF; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 36-2438-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a multifiltrate pro hd had an external leak of the pre-pressure dome ten minutes into a patient¿s continuous renal replacement therapy (crrt) treatment.The patient¿s blood was not returned, and as a result they experienced approximately 50 ml of blood loss.The sample was reported to not be available for evaluation.Additional information requested but has not been obtained.

Event Description

It was reported that a multifiltrate pro hd had an external leak of the pre-pressure dome ten minutes into a patient¿s continuous renal replacement therapy (crrt) treatment.The patient¿s blood was not returned, and as a result they experienced approximately 50 ml of blood loss.The sample was reported to not be available for evaluation.Additional information requested but has not been obtained.

Manufacturer Narrative

Investigation: batch production record controls resulted with conformity and non-conformity was not observed during manufacturing process.There is no other complaint reported for the batch.The reported event is adequately addressed in the instructions for use and/or on the label.There is no indication that the reported failure relates to falsification.The complaint sample is not available.The retained sample examination revealed product conformity and passed leakage test.No failure detected on the retained sample.The complaint was admitted; however, the exact reason of the defect could not be determined due to absence of original sample examination.According to the complaint description and attachment, possible reasons of the defect might be related to component defect or connection failures but not limited to.No unanticipated hazard or harm has been determined during production or assembly process.Cause could not be determined.

• Brand Name: MULTIFILTRATEPRO HDF
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): NOVAMED (ANTALYA); antalya freezone ctr branch; liman s b mah.4. sk.no:16; konyaalti-antalya 07070 ; TU 07070
• Manufacturer (Section G): NOVAMED (ANTALYA); antalya freezone ctr branch; liman s b mah.4. sk.no:16; konyaalti-antalya 07070 ; TU 07070
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18564626
• MDR Text Key: 333497660
• Report Number: 0001225714-2024-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36-2438-0
• Device Lot Number: D9UM143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MULTIFILTRATE PRO KIT CRRT 600.; MULTIFILTRATE PRO KIT CRRT 600.; MULTIFILTRATE PRO.; MULTIFILTRATE PRO.